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Development and Validation of a Premature Ejaculation Diagnostic Tool

DOI:10.1016/j.eururo.2007.01.028
Authors:
Tara Symonds at Pfizer
Tara Symonds
Michael A Perelman at New York Presbyterian Hospital
Michael A Perelman
Stanley Althof at Case Western Reserve University
Stanley Althof
François Giuliano
François Giuliano
François Giuliano
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Abstract and Figures

Diagnosis of premature ejaculation (PE) for clinical trial purposes has typically relied on intravaginal ejaculation latency time (IELT) for entry, but this parameter does not capture the multidimensional nature of PE. Therefore, the aim was to develop a brief, multidimensional, psychometrically validated instrument for diagnosing PE status. The questionnaire development involved three stages: (1) Five focus groups and six individual interviews were conducted to develop the content; (2) psychometric validation using three different groups of men; and (3) generation of a scoring system. For psychometric validation/scoring system development, data was collected from (1) men with PE based on clinician diagnosis, using DSM-IV-TR, who also had IELTs < or =2 min (n=292); (2) men self-reporting PE (n=309); and (3) men self-reporting no-PE (n=701). Standard psychometric analyses were conducted to produce the final questionnaire. Sensitivity/specificity analysis was used to determine an appropriate scoring system. The qualitative research identified 9 items to capture the essence of DSM-IV-TR PE classification. The psychometric validation resulted in a 5-item, unidimensional, measure, which captures the essence of DSM-IV-TR: control, frequency, minimal stimulation, distress, and interpersonal difficulty. Sensitivity/specificity analyses suggested a score of < or =8 indicated no-PE, 9 and 10 probable PE, and > or =11 PE. The development and validation of this new PE diagnostic tool has resulted in a new, user-friendly, and brief self-report questionnaire for use in clinical trials to diagnose PE.
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Sexual Medicine
Development and Validation of a Premature Ejaculation
Diagnostic Tool
Tara Symonds
a,
*, Michael A. Perelman
b
, Stanley Althof
c
, Franc¸ois Giuliano
d
,
Mona Martin
e
, Kathryn May
a
, Lucy Abraham
a
, Anna Crossland
a
, Mark Morris
a
a
Pfizer Ltd, Sandwich, Kent, UK
b
NY Presbyterian, Weill Medical College of Cornell University, New York, NY, USA
c
Case Western Reserve University School of Medicine, Cleveland, OH, USA
d
AP-HP, Raymond Poincare Hospital Garches, Garches, France
e
HRA Inc, Seattle, WA, USA
european urology 52 (2007) 565–573
available at www.sciencedirect.com
journal homepage: www.europeanurology.com
Article info
Article history:
Accepted January 5, 2007
Published online ahead of
print on January 16, 2007
Keywords:
Diagnosis
Premature ejaculation
Diagnostic tool
Orgasmic dysfunction
Rapid ejaculation
Sexual dysfunction
Questionnaire
Score
Abstract
Objectives: Diagnosis of premature ejaculation (PE) for clinical trial purposes has
typically relied on intravaginal ejaculation latency time (IELT) for entry, but this
parameter does not capture the multidimensional nature of PE. Therefore, the
aim was to develop a brief, multidimensional, psychometrically validated instru-
ment for diagnosing PE status.
Methods: The questionnaire development involved three stages: (1) Five focus
groups and six individual interviews were conducted to develop the content;
(2) psychometric validation using three different groups of men; and (3) genera-
tion of a scoring system. For psychometric validation/scoring system develop-
ment, data was collected from (1) men with PE based on clinician diagnosis, using
DSM-IV-TR, who also had IELTs 2 min (n= 292); (2) men self-reporting PE
(n= 309); and (3) men self-reporting no-PE (n= 701).
Standard psychometric analyses were conducted to produce the final ques-
tionnaire. Sensitivity/specificity analysis was used to determine an appropriate
scoring system.
Results: The qualitative research identified 9 items to capture the essence of
DSM-IV-TR PE classification. The psychometric validation resulted in a 5-item,
unidimensional, measure, which captures the essence of DSM-IV-TR: control,
frequency, minimal stimulation, distress, and interpersonal difficulty. Sensitiv-
ity/specificity analyses suggested a score of 8 indicated no-PE, 9 and 10 probable
PE, and 11 PE.
Conclusions: The development and validation of this new PE diagnostic tool has
resulted in a new, user-friendly, and brief self-report questionnaire for use in
clinical trials to diagnose PE.
#2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.
* Corresponding author. Worldwide Outcomes Research (IPC160),
Pfizer Global Research and Development, Ramsgate Road, Sandwich, Kent,
CT13 9NJ, United Kingdom. Tel. +44 1304 641553; Fax: +44 1304 658823.
E-mail address: tara.symonds@pfizer.com (T. Symonds).
0302-2838/$ – see back matter #2007 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2007.01.028
1. Introduction
Premature ejaculation (PE) is the most common
ejaculatory disorder. Epidemiologic studies indicate
that PE has an estimated prevalence of approxi-
mately 16–38% across all age groups of the male
population [1].
Although defined in several ways, the most
widely accepted definition is Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition, Text Revision
(DSM-IV-TR) [2], which uses vague terms such as
‘‘minimal sexual stimulation,’’ ‘‘before the person
wishes it,’’ and ‘‘causes marked distress or inter-
personal difficulty.’’
Traditionally, intravaginal ejaculation latency
time (IELT) has served in clinical trials as an opera-
tional marker for DSM-IV-TR criteria. Frequently,
the IELT inclusion criterion has been set at 1 or
2 min. Waldinger et al [3] found, in their meta-
analysis of PE drug treatment studies, of 41 studies
that used a time-based operational definition 30
used 1 or 2 min as the PE definition. Three minutes
or less was used in 8 studies, and 30 s, 4 min, and
5 min were used in 1 study each. However, the 1- or
2-min cut point does not fit all. There are men who
would still consider themselves premature with an
IELT of 3, 4, or even 5 min, as evidenced by Patrick
et al’s [4] study. Conversely, there are men who do
not consider they have PE with IELTs of 1 or 2 min.
The International Consultation on Sexual Dysfunc-
tions ejaculation committee members [5,6] sug-
gested that IELT, control, and distress elements all
be considered when diagnosing PE, because PE is not
simply a function of time; men also complain of lack
of control, sexual dissatisfaction, and/or concern
about partner dissatisfaction.
Since diagnosis seems to warrant more than just
an assessment of time, it was proposed that a self-
report measure that encompasses the essence of
DSM-IV-TR be developed.
2. Part 1: Pilot tool development
2.1. Method
2.1.1. Study design
Five focus groups (6–7 men each) and six individual
interviews were convened with men who self-
reported having PE, or who were currently receiving
treatment for their PE. The focus groups were
conducted in the United States and Germany.
Because we were advised against use of a focus
group model in Spain, we conducted individual
interviews. Focus groups and interviews were
conducted in subjects’ native language. These
countries were chosen to give a range of cultural
experience. Following this qualitative data collec-
tion, a panel of five clinical experts was then
convened in July 2004 to add input to the process.
The panel members were chosen on the basis of
geographic distribution (France, Australia, United
States), years of experience in diagnosing PE, and to
multidisciplinary variability (sex therapist, primary
care provider, urologist, experimental psychologist).
2.1.2. Study population
2.1.2.1. Focus groups and individual interviews. Recruit-
ment was based on a diagnosis by a physician or
by self-report. Participation in interviews conducted
in Spain was based solely on a man’s self-report of
experiencing PE.
The average age of the men was 44.34 yr (standard
deviation = 11.44). Regardless of marital status, a
current relationship was required for participation;
most (62%) were married. Average years spent in
their current relationship was just under 10. Nearly
40% had middle-class incomes, 65% had at least
some college education, and the group was 72%
Caucasian. The average number of years with PE
was just under 8, and the men had either lifelong or
acquired PE.
2.1.3. Study procedure
2.1.3.1. Focus groups/individual interviews/clinical expert
panel. After informed consent was obtained, partic-
ipants were asked 16 open-ended questions about
their experience with PE and its impact on their
relationship. Example questions included: How
would you describe PE? How do you think your
experience of ejaculation compares with what you
might expect to be a ‘‘normal’’ or usual sexual
experience? How does having PE make you feel
(distressed, angry, frustrated, disappointed, anno-
yed, bothered)? Is ‘‘control’’ an issue for you?
For the expert panel, clinical experts were asked
to present and discuss their clinical experience with
PE, focusing in particular on the process of diag-
nosis.
2.1.4. Results
The results from the qualitative work and expert
panel are summarised below:
When men described their symptoms, they talked
about problems with timing of ejaculation, rather
than lasting a certain amount of time.
They generally rejected the concept that PE could
be defined by absolute time to ejaculation,
particularly as their usual sexual practice tended
european urology 52 (2007) 565–573566
to incorporate other sexual activities. It was
unusual for many of them to have a period of
uninterrupted intercourse culminating in ejacula-
tion.
They identified control over ejaculation as being
important, but this tended to be discussed as a
better degree of continence, rather than absolute
control, which they did not see as realistic.
Most men did not identify with the word ‘‘dis-
tress’’ to describe the emotional impact of their PE.
Rather, the word ‘‘frustration’’ seemed to be the
most appropriate and widely used descriptor.
Components men wanted to see incorporated
into a diagnostic measure were concepts such as:
Ejaculating before you wish to
Inability to delay ejaculation
Inability to control ejaculation
The 9-item PEDT was tested for understanding in
two additional focus groups (United States and
Germany). There were no issues with the content; a
definition of PE was added for clarity. The version in
Appendix A was taken forward for validation.
3. Part 2: validation
3.1. Method
3.1.1. Study design
We recruited a cohort of men with PE defined
according to DSM-IV-TR and known IELT of 2 min
in 70% of coital attempts. These men (all from the
US) were asked to use a stopwatch to time IELT over
a 4-wk duration (time-defined population).
The self-reported population (self-reported PE
and self-reported no-PE) was recruited by using
Harris Interactive Service Bureau (HISB), a US Web-
based survey system. The incentive for being on this
panel was a system of points awarded for surveys
completed, which could then be redeemed at an
online store.
3.1.2. Study populations
3.1.2.1. Time-defined population. In total, 292 men were
recruited, with known IELTs of than 2 min in >70%
of coital attempts.
3.1.2.2. Self-reported population. We categorized as ‘‘self-
reported PE’’ (n= 309) subjects who responded with
‘‘probably yes’’ or ‘‘definitely yes’’ to the following
question: ‘‘Premature ejaculation is a term com-
monly used to refer to the condition when a man
ejaculates before he and/or his partner wants him
to. Given this definition, do you think you suffer
from premature ejaculation?’’ Also, these men had
to have partners who did not have any sexual
problems.
Subjects who responded with either ‘‘definitely
not’’ or ‘‘not sure’’ were categorized as ‘‘self-reported
no-PE’’ (n=701).
3.1.3. Demographics
The demographics for each of the cohorts can be
seen in Table 1.
3.1.4. Study procedure
3.1.4.1. Time-defined population. Men were recruited by
advertisement and were screened with the use
of the following criteria: experienced PE for at least
10 yr, aged 18–65 yr, in a stable relationship for at
least the last 6 mo, fulfilled DSM-IV-TR criteria for
PE, and reported no erectile dysfunction (according
to the International Index of Erectile Function [7]).
Men meeting the initial screening criteria completed
a consent form, provided initial questionnaire
Table 1 – Demographics for the time-defined, self-reported PE, and self-reported no-PE cohorts
Population Time-defined (n= 292) Self-reported PE (n= 309) Self-reported no-PE (n= 701)
Age (yr)
18–41 72% 33% 43%
42–65 28% 67% 57%
Relationship
Yes 100%
a
74% 70%
>1 year 76% 94% 91%
IELT
Mean (SE) 66 s (1.78) 279.4 s (19.22) 490.9 s (36.26)
Median 65 s 180 300
PE = premature ejaculation; IELT = intravaginal ejaculation latency time; SE = standard error.
a
All men in the time-defined population had to be in a stable relationship for at least 6 mo.
european urology 52 (2007) 565–573 567
information (demographics and PEDT), and were
given an explanation of the 4-wk diary process. The
men were then given an electronic diary with
embedded stopwatch to take home to record IELTs
and confirm an IELT of 2 min in 70% of coital
attempts. Each subject was given the option of either
he or his partner operating the stopwatch. Which-
ever partner timed the ejaculation on the first
occasion continued to do so throughout the course
of the 4-wk study. Two weeks after subjects were
enrolled, they received a second PEDT by mail, along
with a self-addressed stamped envelope, to com-
plete and return (for assessing retest reliability). At
the end of the 4-wk period, participants returned
and completed a further PEDT survey.
3.1.4.2. Self-reported population. A survey asking screen-
ing criteria similar to those above was sent out to a
general population of men; it also contained the
PEDT and a question about PE status (as given above)
to confirm the subjects’ belief that they ejaculated
prematurely or did not ejaculate prematurely. IELT
information was not captured for this group because
it was meant to be broad and not constrained by an
IELT cut point.
3.1.5. Statistical analyses
3.1.5.1. Psychometric analyses. Various analyses were
carried out to identify items to include in the final
PEDT (Table 2).
Once the final items for the tool were selected, the
resulting tool was then checked to see that internal
consistency, test-retest reliability, and known-
groups validity still applied.
The psychometric tests listed in Table 2 were
also performed on the self-reported PE population
to explore whether a similar set of items was
selected.
Before agreeing on the final content of the tool,
the psychometric test results were reviewed by
three experts (Drs S. Althof [S.A.], F. Giuliano [F.G.],
M. Perelman [M.P.]).
3.2. Results
3.2.1. Performance of individual items
Item-to-item correlations were acceptable. The
correlation coefficient between items 9 and 4, 5, 7,
and 8 was greater than the predefined critical value
of 0.70 (see Appendix A for item content). The overall
Cronbach alpha for the 9-items was 0.86. Test-retest
reliability was good (0.82), and all items statistically
significantly discriminated between those with PE
and those without PE.
One factor was retained (Eigen value of the first
factor: 4.03), which explained 95% of the variance
and factor loadings >0.4; loadings ranged between
0.41 (item 6) and 0.88 (item 9).
3.2.2. Reduction of the items
Following a discussion with the three experts, items
1, 2, 3, 4, and 8 were retained (see Appendix A).
Although the known-groups validity for each item
was very good, item 6 performed less well at
discriminating between the two populations than
the other eight items. Item 9 failed the prespecified
criterion of an item-to-item correlation of <0.70 with
item 7. It was also highly correlated with items 4, 5,
and 8. Item 7 was highly correlated with items 4 and
5. In addition, there was a high correlation between
items 4 and 5. Items 7 and 9 were deemed redundant
and were removed. Similarly, there was some
redundancy between items 4 and 5; item 5 was
removed.
In terms of clinical face validity, the five selected
items best summarized the essence of DSM-IV-TR.
Items 1–3 covered the concept of control, but 2 and 3
also addressed frequency and minimal sexual
stimulation, respectively. Item 4 addressed the
concept of distress, and item 8 covered the issue
of interpersonal difficulty.
3.2.3. Psychometrics of the 5-item PEDT
Factor analysis of the 5 items retained the one-factor
solution.
The reliability of the 5-item version was good
(Cronbach alpha = 0.71; test-retest reliability = 0.73).
Difference in mean score between the time-defined
population and self-reported no-PE group was
Table 2 – Psychometric analyses
Factor analysis Common factor analysis with Promax
rotation [8]. A priori criteria for
domain identification and item
retention were (1) Eigen values >1.0;
(2) items with factor loadings >0.4
Item-to-item correlation Pearson correlation coefficient was
used; correlation coefficients >0.70
indicate redundancy.
Reliability
Internal consistency Cronbach alpha score 0.7 is
considered good internal consistency.
Test-retest reliability Intraclass correlation coefficient (ICC):
the minimal acceptable level was
defined as 0.70.
Validity
Known-groups validity Independent ttest to determine
whether items could discriminate
between those with PE and those
without PE.
PE = premature ejaculation.
european urology 52 (2007) 565–573568
highly statistically significantly different (mean
difference = 11.8; 95% confidence interval, 11.3–
12.2); p<0.0001).
The psychometrics from the self-reported PE
population confirmed that items 1, 2, 3, 4, and 8
were the best items to retain.
The final version of the tool (Appendix B) was
taken forward for assessment of the most appro-
priate cut score to indicate presence or absence of
PE.
4. Part 3: scoring system
4.1. Method
4.1.1. Sample size
The number of men in the time-defined population
was determined by a general formula for sample
size estimation when constructing a two-sided
confidence interval for single test accuracy on
sensitivity [9].
The minimum number of subjects required for
each cohort (PE and no-PE) was 246.
4.1.2. Sensitivity/specificity analysis
Sensitivity was defined as the proportion of subjects
with the disorder who were diagnosed as having the
disorder (true positive rate); specificity was defined
as the proportion of subjects without the disorder
who were diagnosed as not having the disorder (true
negative rate).
The time-defined population was the source of
information for subjects ‘‘with’’ the disorder. The
no-PE population was used as the group ‘‘without’’
the disorder. The scoring system for the diagnostic
tool was derived from the point at which the
sensitivity/specificity ratio was closest to unity
(this approach maximized both sensitivity and
specificity).
The primary analysis was conducted on the time-
defined PE population and the self-reported no-PE
population. Secondary analysis used the self-
reported PE population and the self-reported no-PE
population.
4.2. Results
4.2.1. Primary analysis: time-defined PE versus self-reported
no-PE (definitely no/not sure)
The diagnostic tool discriminated between the two
cohorts (sample size: 294 vs. 701, respectively)
extremely well, suggesting that both groups were
answering the questions very differently. When
sensitivity/specificity were maximised, a score
between 10 and 11 was the best predictor of PE
status.
4.2.2. Secondary analysis: self-reported PE (definitely yes
and probably yes) versus self-reported no-PE (definitely no
and not sure)
There was a good fit between the two self-reported
cohorts (sample size: 309 vs. 701, respectively). A
score of 7 indicated no-PE and 8 indicated PE.
4.2.3. Additional exploratory analyses
The time-defined versus self-reported no-PE (‘‘defi-
nitely no’’ only, n= 474) had the strongest fit; the two
cohorts clearly responded very differently. The
sensitivity/specificity analysis produced a score of
8 for no-PE and 9 for PE.
The final analysis used men who self-reported PE
as ‘‘definitely yes’’ only (n= 68) versus the full data
set of men who self-reported no-PE (‘‘definitely no’’
and ‘‘not sure’’). A score of 9 indicated no PE and
10 indicated PE.
The data were reviewed and discussed with the
experts. The scoring system was set at 11 to
suggest a diagnosis of PE. Since the predicted cut
point between PE and no-PE status went as low as
8, and the ‘‘not sure’’ group would have a score
between 9 and 10, it was agreed that ‘‘probable PE’’
should be defined in this range; any man scoring a 9
or 10 would necessitate further assessment. A score
below 9 would indicate low likelihood of PE.
5. Discussion
A literature search revealed only one tool that
purported to discriminate PE from non-PE: Chinese
Index of Premature Ejaculation [10]. However, it was
developed as an efficacy measure and did not
specifically address the DSM-IV-TR criteria. This
study’s objective was to develop a validated, short
tool using DSM-IV-TR classification criteria to
diagnose PE. While individual clinicians rely on
the DSM-IV-TR criteria, there is wide variability in
application. The PEDT was developed to standardise
the diagnosis of PE in future clinical trials and was
designed to capture the main elements of DSM-IV-
TR: control, frequency, minimal sexual stimulation,
distress, and interpersonal difficulty. These ele-
ments mirrored the patient concerns arising in focus
groups and individual interviews. In fact, from the
focus groups, it was clear that PE’s impact on
men was primarily one of lack of control and
emotional impact on the man and his partner.
These concerns accounted for the large number of
emotional concepts incorporated into the draft tool
european urology 52 (2007) 565–573 569
to determine which emotional descriptor was
relevant to most men (frustration, lack of confi-
dence, dissatisfaction, and disappointment). Feel-
ings of lack of confidence were previously shown to
be the most common complaint associated with PE
[11]. However, in attempting to capture the essence
of distress it was the word ‘‘frustration’’ that most
resonated with the men interviewed. Some men felt
that ‘‘distress’’ was more a female-oriented concept,
and others believed this term was too strong for
what they felt about their condition. These same
views had been previously cited by men in other
focus groups during the development of an outcome
measure: Index of Premature Ejaculation [12];
‘‘distress’’ is now defined as ‘‘frustration’’ in this
measure. The psychometric analyses confirmed this
item best captured men’s distress/emotional impact
of experiencing PE. Also, Symonds et al [11] high-
lighted that men were aware of the impact of PE on
their relationship, showing that such an item in any
diagnostic tool is very relevant.
Overall, the final combination of items showed
excellent psychometric properties supporting its
validity and reliability. The subsequent sensitivity/
specificity analyses suggested a consistent cut score
of 8 ‘‘no PE,’’ 9 and 10 ‘‘probable PE,’’ and 11 ‘‘PE.’’
This result was obtained despite the fact that the
self-reported PE men were older than the time-
defined PE men and was collected via an Internet
panel. Using an Internet system to select the self-
reported PE population could have resulted in a quite
dissimilar group; however, educational background,
ethnicity, and relationship history were all similar.
The difference observed in IELTs was expected as
Waldinger et al’s [13] earlier research showed self-
reported estimates of IELT tend to be higher than
those recorded using a stopwatch. While age differ-
ence was not expected, the younger age may have
been driven by the fact that men had to take home an
electronic diary to record IELT, and that younger men
may be more confident in usingelectronics. However,
the wide spectrum of ages and the fact that the time-
defined/self-reported PE populations had very dif-
ferent IELTs strengthen the PEDT’s applicability
across a broad group of men with PE.
The PEDT will help overcome the variability of
application of DSM-IV-TR criteria and allow clinicians
to have a sense of assurance that a patient merits
diagnosis and treatment. The clinician, whose
patient scores ‘‘probable PE,’’ will be appropriately
prompted to investigate further to determine actual
PE status.
In the absence of a gold standard for diagnosing
PE and evidence of variation in the relationship
between absolute time and PE, the next step for
testing the PEDT’s validity will be to test it against
expert clinician diagnosis. This step will allow
consideration of any danger of ‘‘overdiagnosis’’ by
the tool. Since we know that IELT is culturally
dependent [14], the PEDT’s cross-cultural applica-
bility must also be researched further.
6. Conclusions
The PEDT is a short, psychometrically validated
measure that can be easily administered to facilitate
the diagnosis of PE.
Conflicts of interest
Tara Symonds, Kathryn May, Lucy Abraham, Anna
Crossland, and Mark Morris are all Pfizer Inc
employees.
Michael Perelman, Stanley Althof, and Franc¸ois
Giuliano are paid consultants to Pfizer Inc.
Mona Martin has no conflict of interest.
european urology 52 (2007) 565–573570
Appendix A. Draft Diagnostic Tool
european urology 52 (2007) 565–573 571
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Appendix B. Final PE Diagnostic Tool
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european urology 52 (2007) 565–573 573
... 13 The person's medical and sexual history is taken into account when evaluating PE. 15 Yet, it is important to consider criteria such as intravaginal ejaculatory latency time, ejaculation control, and distress. 16 The Premature Ejaculation Diagnostic Tool (PEDT) 17,18 is an instrument to evaluate PE. 19 This self-report tool consists of 5 items grouped into a single factor. The items refer to criteria of the DSM-IV-TR (ie, text revision) 20 : ejaculation control, frequency of PE, minimum sexual stimulation, anxiety, and interpersonal difficulty. ...
... The scale obtained adequate psychometric properties and good evidence of reliability, with a test score of 0.73 and Cronbach alpha score of 0.71. The sensitivity and specificity of the scale were also analyzed, and the scale's cutoff point was obtained: scores ≤8 indicated the absence of PE; 9 and 10, the probable presence of PE; and ≥11, the presence of PE. 17 Although evidence of the reliability and validity of the PEDT has been reported, the instrument still needs to be adapted to different populations. 19 Thus, the scale has been translated into other languages (English, Finnish, French, German, Hebrew, Hungarian, Italian, Norwegian, Polish, Portuguese, Spanish, Swedish, and Turkish), 18 but it has been adapted and validated only in Turkey, 21 Korea, 19 Finland, 22 Iran, 23,24 and China. ...
... The PEDT is a self-reporting instrument that consists of 5 items that evaluate the presence or absence of premature ejaculation. 17,18 The items correspond to the following areas: ejaculation control (items 1 and 3), frequency of PE (item 2), minimum sexual stimulation (item 3), anxiety (item 4), and interpersonal difficulty (item 5). Response options were given on a Likert-type scale, with possible scores between 0 and 4. Higher values indicate more PE symptoms. ...
Translation, adaptation, and clinical validation of the Premature Ejaculation Diagnostic Tool in Spanish (Colombia)
Article
Full-text available
  • Jan 2023
Background Premature ejaculation is the most prevalent form of sexual dysfunction in men. The Premature Ejaculation Diagnostic Tool (PEDT) is an instrument used to evaluate premature ejaculation. It offers adequate psychometric properties and good reliability. Aim To adapt and validate a Colombian version of the PEDT in Colombian clinical and nonclinical samples. Methods Two samples were used in this study. The first was made up of 1110 men who were recruited to evaluate validity and reliability. Their ages ranged from 19 to 65 years (mean ± SD, 39.71 ± 12.53). The second sample included 123 men (66.7%) who did not meet diagnostic criteria for premature ejaculation per the International Statistical Classification of Diseases and Related Health Problems (ICD-10), while 33.3% met ICD-10 criteria for this dysfunction. Their ages ranged from 18 to 65 years (34.19 ± 12.65). Scores were used to calculate the cutoff. Outcomes A translated and adapted version of the PEDT was developed specifically for Colombia. All participants completed the Colombian version of the PEDT, a sociodemographic questionnaire, the Colombian version of the Massachusetts General Hospital–Sexual Functioning Questionnaire, and a semistructured interview based on the ICD-10. Results The results showed adequate psychometric properties and satisfactory internal consistency and confirmed the 1-dimensional factorization of the scale. According to ICD-10 criteria, the study also confirmed significant differences between participants who self-reported premature ejaculation and those who did not. In addition, it showed adequate evidence of convergent validity, with a moderate correlation with sexual functioning scores. As a result, the cutoff point was set to 10.5, with an area under the curve of 96.8%. Therefore, a score ≥11 points suggested the presence of premature ejaculation. Clinical Translation The current Colombian version of the PEDT is a useful instrument that determines the presence of premature ejaculation that is compatible with ICD-10 criteria. Strengths and Limitations The Colombian version of the PEDT presents evidence of reliability and validity, a confirmed 1-dimensional factorization, and a cutoff point for Hispanic populations. More in-depth evaluation of the diagnosis of premature ejaculation is required, and further research among other Spanish-speaking countries and sexual minorities is recommended. Conclusion The Colombian version of the PEDT is a psychometric adequacy tool for evaluating and diagnosing premature ejaculation, following the ICD-10 criteria.
... This section also evaluated the estimated ejaculation latencies (EL) as well as frequencies of partnered sex, masturbation, and pornography use during masturbation. The third section addressed common sexual dysfunctions in men during partnered sex and masturbation and included relevant items from the International Index of Erectile Function, abridged version (IIEF-5) [15] and the Premature Ejaculation Diagnostic Tool (PEDT) [16], as well as questions aimed at assessing DE (see below). ...
... PE during partnered sex was assessed using three of the five items from the PEDT [16] focusing on ejaculatory control, the construct most central to characterizing PE [17,18]. Two items related to "bother/distress" were not included as they represent consequences of PE. ...
... That is, the responses of those men within the sample having no dysfunction (the large majority) typically cluster around one or two response categories, whereas the smaller proportion of men experiencing the dysfunction typically show graded deviations from the predominant response categories selected by men without sexual impairment. This pattern-demonstrated by several of our variables-is also characteristic of such measures as the IIEF and PEDT in samples involving both men with and without the sexual dysfunction being assessed [15,16]. ...
Description of and Relationships among Potential Variables Supported for the Diagnosis of Delayed Ejaculation
Article
Full-text available
  • Jan 2023
The lack of empirically based diagnostic criteria for delayed ejaculation (DE) not only undermines confidence in the reported prevalence rates for this sexual dysfunction, but it has also resulted in a lack of validated patient reported outcomes (PROs) for assessing this condition. The current study was designed to describe and evaluate six face-valid variables previously shown to discriminate between men with and without DE for their utility as diagnostic measures for DE. A sample of 1285 men (mean age = 37.8, SD = 12.7) free of erectile problems and premature ejaculation completed an online sexual health survey that included potential questions intended for use in the diagnosis of DE. Questionnaire items included ones reflective of previously proposed diagnostic constructs related to DE: ejaculation timing/latency, ejaculation efficacy/control, and negative effects of DE. Results indicated that five of the six proposed items showed moderate intercorrelations, suggesting that each constituted a distinct (i.e., non-redundant) though relevant criterion related to the diagnosis of DE. Based on the level of interrelatedness, the better items representing each construct were included in commonality analysis to assess their unique contributions to the diagnosis of DE. Perceived lack of ejaculatory efficacy/control contributed the largest portion of the variance to the diagnosis of DE (58%), with bother/distress (an index of the negative effects of DE) contributing the second largest portion (25%), and ejaculation timing/latency contributing only a small portion of the variance (6%) to the diagnosis of DE. The relevance of these findings to developing a patient report outcome (PRO) for diagnosing DE that considers both empirically supported questions/items and an appropriate balance of items regarding the three constructs was discussed.
... In the beginning of the study, participants completed the PEDT assessment, which has been demonstrated to have strong validity and reliability in assessing PE (Symonds et al., 2007). The PEDT asked participants to answer five questions on a 1 to 5-point scale about difficulty delaying ejaculation (response options: "very easy," 'somewhat easy "neither easy nor difficult," "somewhat difficult" and "very difficult"), ejaculating before desired, ejaculation with very little stimulation (response options: "almost never or never," "less than half the time," "about half the time," "more than half the time" and "almost always or always"), frustration with ejaculating before desired, and perception of whether time to ejaculation affected sexual fulfillment of their partner (response options: "not at all," "slightly," "moderately," "very" and "extremely"). ...
... The PEDT asked participants to answer five questions on a 1 to 5-point scale about difficulty delaying ejaculation (response options: "very easy," 'somewhat easy "neither easy nor difficult," "somewhat difficult" and "very difficult"), ejaculating before desired, ejaculation with very little stimulation (response options: "almost never or never," "less than half the time," "about half the time," "more than half the time" and "almost always or always"), frustration with ejaculating before desired, and perception of whether time to ejaculation affected sexual fulfillment of their partner (response options: "not at all," "slightly," "moderately," "very" and "extremely"). In accordance with the validation of the PEDT assessment, a score of 11 or more was associated with the diagnosis of PE, a score of 9 and 10 was considered as probable PE, and a score of 8 or less indicated no PE (Symonds et al., 2007). In addition, to the PEDT, participants provided data once every 4 weeks on the product impact on their sexual experience. ...
... Written and verbal consent was received from 150 male participants that were eligible in accordance with the specified criteria, with 75 being allocated to each group. The PEDT score at baseline was 15 ± 0.5 for the placebo and 14.9 ± 0.5 for the treatment group, indicating a clinical diagnosis of PE in accordance with the PEDT scoring scale (Symonds et al., 2007). Cronbach's alpha in the current sample was 0.89, indicating high consistency. ...
The Effects of Steady Freddy, a Lidocaine-Based Pump Spray for the Treatment of Premature Ejaculation (PE)
Article
Full-text available
Premature ejaculation (PE) is reported to be the most common sexual dysfunction in men and is defined as the inability to control or delay ejaculation. Steady Freddy is a lidocaine-based ejaculation-delaying spray. This article examines the effects of Steady Freddy on the sexual experience of men that have self-reported to suffer from PE. Under the conditions of a randomized single-blind placebo-controlled clinical trial, 150 participants received either placebo or treatment for the duration of 12 weeks and completed an internet-based questionnaire for the quality of their sexual experience. Prior to product usage, participant average latency time was <1 min, 70% claimed to be very sexually dissatisfied, and 67% claimed to be very dissatisfied with ejaculation control. Upon product usage, sexual experience was significantly improved (p<.01). Participant average latency time increased to >2 min, 80% claimed to be sexually satisfied, and 70% claimed to be satisfied with ejaculation control. These effects were not present in the placebo group throughout the trial. These findings provide evidence for the effectiveness of Steady Freddy in significantly improving the quality of sexual experience and suggest that Steady Freddy can assist with PE.
... The Chinese Index of Premature Ejaculation (CIPE-5) [33], Arabic Index of Premature Ejaculation (AIPE) [34], Multiple Indicators of Premature Ejaculation (MIPE) [35], Checklist for Early Ejaculation Symptoms (CHEES) [36] and Scoring System for Assessment of Premature Ejaculation Treatment Outcomes (SSAPETO) [37] included an objective measurement of measured time to ejaculation, thus combining assessment of subjective elements with the more traditional measurement of IELT. The Premature Ejaculation Diagnostic Tool (PEDT) [38], Index of Premature Ejaculation (IPE) [39] and Premature Ejaculation Profile (PEP) [40] do not include an objective time measurement and focus entirely on subjective experience. Both the PEP and PEDT are short and easily delivered (4 and 5 questions, respectively) and both generate numerical scores, unlike the IPE. ...
... Disorders of ejaculation Able to discriminate between patients who have PE and those who do not [4] (PEDT [38], AIPE [34]). Able to characterise and assess treatment effects [4] (PEP [40], IPE [39], MSHQ-EjD [42]) Useful for clinical research and an 'icebreaker' in discussion but not required for diagnosis [52] (PEDT [38], PEP [40], IPE [39], MIPE [35]) ...
... Disorders of ejaculation Able to discriminate between patients who have PE and those who do not [4] (PEDT [38], AIPE [34]). Able to characterise and assess treatment effects [4] (PEP [40], IPE [39], MSHQ-EjD [42]) Useful for clinical research and an 'icebreaker' in discussion but not required for diagnosis [52] (PEDT [38], PEP [40], IPE [39], MIPE [35]) ...
Atlas of 35 patient reported outcome measures (PROMs) in andrology: a comprehensive overview of literature
Article
Full-text available
Introduction Disorders of male sexual health and functioning are complex and can have significant deleterious effects on patients psychological wellbeing and interpersonal relationships. It is well recognised that clinicians have an overall poor understanding of the true effect that disease has on their patients and self-reported patient-reported outcome measures (PROMs) aim to better communicate these issues. PROMs are generally welcomed by patients and their use in this highly sensitive area of clinical practice is well recognised. An atlas of available PROMs for key conditions in andrology is presented in this article. Methods A comprehensive search of world literature was conducted from the inception of databases to June 2022, to identify male-specific PROMs relevant to four key andrological disorders: hypogonadism, erectile dysfunction, penile curvature and disorders of ejaculation. Each tool was evaluated in narrative format. Results 35 PROMs were identified. 6 were designed for the assessment of hypogonadism, 18 for erectile dysfunction, one for penile curvature and 10 for ejaculatory disorders. In general, PROMs were brief, self-administered and user-friendly. There was sufficient scope and variety in all categories (apart from penile curvature) to give the clinician flexibility in tool selection and find an appropriate tool for different scenarios. Conclusion A number of PROMs exist within andrology that can be utilised in both research and clinical settings. PROMs enable subjective evaluation of difficult-to-assess aspects of the patient experience.
... All patients had a Premature Ejaculation Diagnostic Tool (PEDT) score of greater than 9. The premature ejaculation diagnostic tool (PEDT), which is a brief self-administered questionnaire, was developed and validated by Symonds et al. to standardize the diagnosis of PE in clinical trials (8). The PEDT was validated to a five-item Turkish version by Şerefoğlu et al (9). ...
... The PEDT scores and IELT values of the participants were measured at baseline before PRM training (T0) and at the third (T3) month after the start of training. Figure 1and While the patient's mean±SD (range) baseline PEDT score was 16.26 ± 1.94 (13)(14)(15)(16)(17)(18)(19)(20) and at T3 this was 10.631 ± 1.14 (8)(9)(10)(11)(12)(13). Comparing these results statistically, there was a significant decrease in PEDT scores between T0 and T3 (p=0.021) ...
Regular penis-root masturbation: a promising behavioral treatment method for lifelong premature ejaculation
Preprint
Full-text available
  • Jan 2023
Purpose Premature ejaculation (PE) is a common male sexual dysfunction. Various treatments have been proposed for PE, including pharmacotherapy, behavioral therapy (BT), and combined BT and pharmacotherapy. Although pharmacotherapy is accepted as the first-line treatment for lifelong PE, high rates of discontinuation occur due to variable efficacy and side effects. In this study, the efficacy of penis-root masturbation (PRM), a newly described BT technique, was investigated in patients in whom medical treatment for PE was not successful. Material and Methods The study included 35 patients aged 25-43 years, who were diagnosed with lifelong PE. Patients and their partners were informed about the PRM technique and asked to practice PRM three times a week for three months, with or without sexual intercourse. The patients' Premature Ejaculation Diagnostic Tool (PEDT) scores and intravaginal ejaculatory latency time (IELT) were recorded and compared before PRM training (T0) and at the third (T3) month after the start of PRM training. Results The mean±SD PEDT scores were 16.26±1.94 at T0, 10.63±1.14 at T3. When compared to T0, the PEDT values at T3 were significantly lower (p=0.021). In terms of IELT, the mean T3 values (192.43±56.71) were significantly longer (p=0.035) than at T0 (50.43±13.84 seconds). Conclusion PRM BT shows promise for lifelong PE patients who do not benefit from or discontinue to pharmacotherapy. Larger prospective trials are required to confirm these findings. Key words: Life-long premature ejaculation, penis root masturbation, behavioral therapy
... 18 All of these factors are largely neglected in the PROMs questionnaires and must therefore be investigated through the use of specific surveys, such as the International Index of Erectile Function (IIEF-15), the Premature Ejaculation Diagnostic Tool (PEDT), and the Body Image Scale (BIS), which address the multidimensional aspects of these issues. [19][20][21][22] There is a paucity of data in the literature regarding the frequency with which TC patients attempt fatherhood after cancer treatments. These studies examine the correlation between previous cancer treatments and fatherhood. ...
... A score of 0-4 is given to each of the 5 questions that examine the possible alteration of semen release. 20 The Body Image Scale (BIS) is a full validated 10-item self-rating scale developed to evaluate changes in the body image of cancer patients. It focuses on how cancer patients feel about their appearance and on changes in appearance due to cancer and/or treatment. ...
Patient Reported Outcomes, Paternity, Relationship, and Fertility in Testicular Cancer Survivors: Results from a Prospective Observational Single Institution Trial
Article
Full-text available
  • Dec 2022
Purpose: Testicular cancer (TC) is the most common solid tumor in young adults. 95% of patients are cured, but they may experience late adverse effects (anxiety, fear of recurrence, and sexual dysfunction) with an impact on daily life. We attempted to assess Patient Reported Outcomes (PROMs), long-term sexual disorders, and difficulties in achieving fatherhood in a cohort of TC survivors, as well as their possible correlation with previous cancer treatments. Methods: Different questionnaires, such as the Impact of Cancer (IOC) and the Body Image Scale (BIS), were used to investigate the distinct areas of the PROMs. International Index of Erectile Function (IIEF15) and the Premature Ejaculation Diagnostic Tool (PEDT) focused on sexuality and fertility. Patients were prospectively recruited between February 2020 and February 2022. Results: 144 participants completed all the questionnaires. Results showed a good QoL, a moderate fear of TC recurrence, a good satisfaction with their personal body image, low incidence of premature ejaculation and erectile dysfunction. 19.5% of patients who had a testicular implant reported general dissatisfaction. Only 18% of patients had unsuccessfully attempted fatherhood, while the majority had not yet tried, and 23.4% succeeded. A low percentage of patients used procedures assisted reproduction and adoption. Conclusion: This trial supports the use of various questionnaires as a multifactorial tool capable of investigating all the aspects of long-term cancer survivorship. The assessment of medical and psychosocial sequelae is an essential part of patient care and is important for the development of a comprehensive care plan for TC survivors.
... The first 3 items cover the concept of control, but items 2 and 3 also assess frequency and minimal sexual stimulation, respectively. Items 4 and 5 cover distress and interpersonal difficulty caused by PE. 9 In clinical practice and research, the SHIM is widely used to screen and diagnosis erectile dysfunction (ED) and its severity. The positive impact on understanding and improving male sexual function has been confirmed by the quantity and quality of research already published on the SHIM. 10 The EHS examines a single-item patient-reported outcome for scoring erection hardness. ...
The Men’s Training Cup Keep Training: a masturbation aid improves intravaginal ejaculatory latency time and Erection Hardness Score in patients who are unable to delay ejaculation
Article
Full-text available
  • Jan 2023
Introduction Premature ejaculation (PE) has negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy. In Japan, no oral drugs or devices are approved or used clinically to treat PE. The Men’s Training Cup Keep Training (MTCK), a masturbation aid, was developed for PE. MTCK offers 5 grades of tightness and strength. Aim We aimed to investigate the efficacy of the MTCK in patients who are unable to delay ejaculation. Methods Inclusion criteria were 20- to 60-year-old men feeling distressed and frustrated by PE and who had the same sexual partners throughout the study period. Exclusion criteria were neurologic disease and uncontrolled diabetes mellitus, as well as the use of antidepressants, α-blockers, and 5α-reductase inhibitors. The protocol comprised an 8-week training period with the MTCK from level 1 to level 5, with each level used twice before moving to the next level. Outcome Measures The main outcome measure was the extension of intravaginal ejaculation latency time (IELT). The secondary outcome measures were score improvements on the Premature Ejaculation Diagnostic Tool, Sexual Health Inventory for Men, Erection Hardness Score, and Difficulty in Performing Sexual Intercourse Questionnaire–5. Results We enrolled 37 patients, and after 19 patients withdrew, 18 concluded the study without experiencing any adverse events. The mean patient age was 39.9 years. Geometric IELT after the 8-week training with the MTCK increased significantly (mean ± SE; 232.10 ± 72.16 seconds) vs baseline (103.91 ± 50.61 seconds, P = .006). Mean scores on the Premature Ejaculation Diagnostic Tool, Difficulty in Performing Sexual Intercourse Questionnaire–5, and Erection Hardness Score after 8-week training improved significantly vs the baseline values. The mean score on the Sexual Health Inventory for Men did not improve significantly after the 8-week training, but domain 1 did significantly improve after 8 weeks of MTCK use. Clinical Implications The MTCK may be one possible treatment option for patients who are unable to delay ejaculation. Strengths and Limitations This is the first study to show that the MTCK is effective for patients who are unable to delay ejaculation. A major limitation is that the present study was not strictly limited to an IELT <3 minutes. Conclusions The MTCK may offer benefits not only for delay of ejaculation but also for erectile function.
... 19 This includes the inability to delay ejaculation in all or nearly all vaginal penetrations; negative personal consequences, such as distress and frustration; IELT <2 minutes in at least 75% of coituses; and no attempts >3 minutes. Patients were asked to complete the Premature Ejaculation Diagnostic Tool (PEDT), a validated self-administered 5-item brief diagnostic measure to assess self-perceived PE, 20 and the erectile function domain of the International Index of Erectile Function (IIEF-5). 21 Patients with a PEDT score ≥11 and an IIEF-5 score>22 were included. ...
A novel on-demand therapy for lifelong premature ejaculation using a miniature transperineal electrical stimulator—the vPatch: an as-treated analysis
Article
  • Jan 2023
Background While premature ejaculation (PE) is a common and disturbing sexual dysfunction in men, current available treatment modalities have limited efficacy and low treatment adherence. Aim To assess the feasibility, safety, and efficacy of the vPatch, a miniaturized on-demand perineal transcutaneous electrical stimulation device for treating PE. Methods This prospective bicenter international first-in-human clinical study consisted of 2 arms, was sham controlled, and had a randomized double-blind design. In terms of statistical power calculation, 59 patients aged 21 to 56 years (mean ± SD, 39.8 ± 9.28) with lifelong PE were included. During the initial visit, intravaginal ejaculatory latency time (IELT) was measured over a 2-week run-in period. Eligibility was confirmed in visit 2, based on IELT values, medical and sexual history, and patients’ individualized sensory and motor activation thresholds during perineal stimulation with the vPatch. Patients were randomized to the active (vPatch) and sham device groups in a 2:1 ratio, respectively. The vPatch device’s safety profile was determined by comparing the incidence of treatment-emergent adverse events. During visit 3, IELTs, Clinical Global Impression of Change scores, and Premature Ejaculation Profile questionnaire outcomes were recorded. Primary end points assessed vPatch device efficacy as mean change in geometric mean IELT; each person was compared with himself, with and without the device, and the sham group was compared with the active group. Outcomes Outcomes included changes in IELT and Premature Ejaculation Profile before and after treatment, last visit Clinical Global Impression of Change scores, and vPatch safety profile. Results Of 59 patients, 51 completed the study: 34 in the active group and 17 in the sham group. The baseline geometric mean IELT significantly increased from 67 to 123 seconds (P < .01) in the active group, as compared with an insignificant increase from 63 to 81 seconds (P = .17) in the sham group. The increase in mean IELT in the active group was significantly higher than in the sham group (56 vs 18 seconds, P = .01). IELT significantly increased by 3.1 times in the active vs sham group. The mean ratio of fold change (active:sham) was 1.4, significantly different from 1.0 (P = .02). No serious adverse events were reported. Clinical Implications Therapeutic use of the vPatch during coitus may become an on-demand, noninvasive, and drug-free treatment for PE. Strengths and Limitations To our knowledge, this is the first rigorous study investigating whether transcutaneous electrical stimulation during coitus could improve the symptoms of men with lifelong PE. The study is limited by the small number of patients, the exclusion of patients with acquired PE, the short-term follow up, and the use of a device based on a theoretic mechanism of action. Conclusion We demonstrated the possibility to treat lifelong PE by prolonging coitus on demand, using electric stimulation of ejaculation muscles with the vPatch. Clinical trial registration: NCT03942367 (ClinicalTrials.gov).
The impact of prostate biopsy on erectile and ejaculatory function: A prospective study
Article
Full-text available
  • Dec 2022
Objective: To evaluate the impact on erectile and ejaculatory function following transrectal ultrasound-guided biopsies of the prostate (TRUS-Bx) in sexually active men. Methods: Monocentric prospective study from May 2021 to January 2022 of consecutive patients with suspected prostate cancer [elevated prostate specific antigen (PSA) level and/or abnormal digital rectal examination] undergoing TRUS-Bx. The 15-item version of the International Index of Erectile Function (IIEF-15), Premature Ejaculation Diagnostic Tool (PDET) and short form of Male Sexual Health Questionnaire (MSHQ-EjD Short Form) were assessed before, one and three months after TRUS-Bx. The primary endpoint was to evaluate the risk of temporary post-biopsy erectile and/or ejaculatory dysfunctions. The statistical significance was set as p value < 0.05. Results: A total of 276 consecutive patients were included in the study. The median age, PSA and biopsy cores were 65 years (IQR 59-69), 7 ng/ml (IQR 5-9.7) and 16 (IQR 12-16), respectively. We compared the IIEF subdomains before TRUS-Bx vs. one or three months: the erectile function (EF) decreased after one month (p
Sexual function of premature ejaculation patients assayed with Chinese Index of Premature Ejaculation
Article
Full-text available
  • Jul 2004
To assess the psychometric properties of the Chinese Index of Premature Ejaculation (CIPE). The sexual function of 167 patients with and 114 normal controls without premature ejaculation (PE) were evaluated with CIPE. All subjects were married and had regular sexual activity. The CIPE has 10 questions, focusing on libido, erectile function, ejaculatory latency, sexual satisfaction and difficulty in delaying ejaculation, self-confidence and depression. Each question was responded to on a 5 point Likert-type scale. The individual question score and the total scale score were analyzed between the two groups. There were no significant differences between the age, duration of marriage and educational level (P> 0.05) of patients with and without PE and normal controls. The mean latency of patients with PE and normal controls were 1.6 +/- 1.2 and 10.2 +/- 9.5 minutes, respectively. Significant differences between patients with (26.7 +/- 4.6) PE and normal controls (41.9 +/- 4.0) were observed on the total score of CIPE (P< 0.01). Using binary logistic regression analysis, PE was significantly related to five questions of the original measure. They are the so-called the CIPE-5 and include: ejaculatory latency, sexual satisfaction of patients and sexual partner, difficulty in delaying ejaculation, anxiety and depression. Receiver Operating Characteristic (ROC) curve analysis of CIPE-5 questionnaire indicated that the sensitivity and specificity of CIPE were 97.60 % and 94.74 %, respectively. Employing the total score of CIPE-5, patients with PE could be divided into three groups: mild (>15 point) 19.8 %, moderate (10-14 point) 62.8 % and severe (< 9 point) 16.7 %. The CIPE-5 is a useful method for the evaluation of sexual function of patients with PE and can be used as a clinical endpoint for clinical trials studying the efficacy of pharmacological intervention.
Sexual function of premature ejaculation patients assayed with Chinese Index of Premature Ejaculation
Article
  • Jan 2004
AIM: To assess the psychometric properties of the Chinese Index of Premature Ejaculation (CIPE). METHODS: The sexual function of 167 patients with and 114 normal controls without premature ejaculation (PE) were evaluated with CIPE. All subjects were married and had regular sexual activity. The CIPE has 10 questions, focusing on libido, erectile function, ejaculatory latency, sexual satisfaction and difficulty in delaying ejaculation, self-confidence and depression. Each question was responded to on a 5 point Likert-type scale. The individual question score and the total scale score were analyzed between the two groups. RESULTS: There were no significant differences between the age, duration of marriage and educational level (P> 0.05) of patients with and without PE and normal controls. The mean latency of patients with PE and normal controls were 1.6 +/- 1.2 and 10.2 +/- 9.5 minutes, respectively. Significant differences between patients with (26.7 +/- 4.6) PE and normal controls (41.9 +/- 4.0) were observed on the total score of CIPE (P< 0.01). Using binary logistic regression analysis, PE was significantly related to five questions of the original measure. They are the so-called the CIPE-5 and include: ejaculatory latency, sexual satisfaction of patients and sexual partner, difficulty in delaying ejaculation, anxiety and depression. Receiver Operating Characteristic (ROC) curve analysis of CIPE-5 questionnaire indicated that the sensitivity and specificity of CIPE were 97.60 % and 94.74 %, respectively. Employing the total score of CIPE-5, patients with PE could be divided into three groups: mild (>15 point) 19.8 %, moderate (10-14 point) 62.8 % and severe (< 9 point) 16.7 %. CONCLUSION: The CIPE-5 is a useful method for the evaluation of sexual function of patients with PE and can be used as a clinical endpoint for clinical trials studying the efficacy of pharmacological intervention.
Incidence and prevalence of the sexual dysfunctions: A critical review of the empirical literature
Article
  • Sep 1990
The research which has assessed the incidence and prevalence of sexual dysfunctions is reviewed. Twenty-three studies are evaluated. Studies completed with community samples indicate a current prevalence of 5-10% for inhibited female orgasm, 4-9% for male erectile disorder, 4-10% for inhibited male orgasm, and 36-38% for premature ejaculation. Stable community estimates with regard to the current prevalence of female sexual arousal disorder, vaginismus, and dyspareunia are not available. Recent studies completed with clinical samples suggest an increase in the frequency of orgasmic and erectile dysfunction and a decrease in premature ejaculation as presenting problems. Desire disorders have increased as presenting problems in sex clinics, with recent data indicating that males outnumber females. Methodological limitations of these studies are identified and suggestions for future research are offered.
Incidence and prevalence of the sexual dysfunctions: a critical review of the empirical literature
Article
  • Jan 1990
The research which has assessed the incidence and prevalence of sexual dysfunctions is reviewed. Twenty-three studies are evaluated. Studies completed with community samples indicate a current prevalence of 5-10% for inhibited female orgasm, 4-9% for male erectile disorder, 4-10% for inhibited male orgasm, and 36-38% for premature ejaculation. Stable community estimates with regard to the current prevalence of female sexual arousal disorder, vaginismus, and dyspareunia are not available. Recent studies completed with clinical samples suggest an increase in the frequency of orgasmic and erectile dysfunction and a decrease in premature ejaculation as presenting problems. Desire disorders have increased as presenting problems in sex clinics, with recent data indicating that males outnumber females. Methodological limitations of these studies are identified and suggestions for future research are offered.
Statistical Methods in Diagnostic Medicine John W
Article
  • Jan 2002
Binary-Scale Data Ordinal- and Continuous-Scale Data Tests of Equivalence
An empirical operational study of DSM-IV diagnostic criteria for PE
Article
  • Dec 1998
The DSM-IV diagnostic criteria for premature ejaculation remain to be investigated by a clinical study. A prospective study was therefore conducted to investigate the DSM-IV definition and to provide an empirical operationalization of premature ejaculation. In this study 140 men suffering from lifelong premature ejaculation were interviewed separately from their partners. Various means of assessing the intravaginal ejaculation latency time (IELT) were compared: assessment by spontaneous answer, by questionnaire, by imagining foreplay and intercourse and estimating the ejaculation time without a clock or with a clock, and by stop-watch measurement at home over a one-month period. The number of thrusts and feelings of control during foreplay and intercourse were also assessed. A total of 110 men used the stop-watch method. Ninety percent of all the subjects ejaculated within one minute of intromission, with 80% actually ejaculating within 30 seconds. The age of the men and duration of their relationship were not correlated with IELT; however, the IELT tended to be longer for couples who had a higher frequency of intercourse. There was only a moderate correlation between the various methods of assessing IELT. The results suggest that premature ejaculation could be operationally defined as an IELT < 1 min in more than 90% of episodes of sexual intercourse, independent of age and duration of relationship.
Statistical Methods in Diagnostic Medicine, Second Edition
Book
  • Jan 2002
Sensitivity and Specificity Combined Measures of Sensitivity and Specificity Receiver Operating Characteristic (ROC) Curve Area Under the ROC Curve Sensitivity at Fixed FPR Partial Area Under the ROC Curve Likelihood Ratios ROC Analysis When the True Diagnosis Is Not Binary C-Statistics and Other Measures to Compare Prediction Models Detection and Localization of Multiple Lesions Positive and Negative Predictive Values, Bayes Theorem, and Case Study 2 Optimal Decision Threshold on the ROC Curve Interpreting the Results of Multiple Tests
A Multinational Population Survey of Intravaginal Ejaculation Latency Time
Article
Introduction: Intravaginal ejaculation latency time (IELT), defined as the time between the start of vaginal intromission and the start of intravaginal ejaculation, is increasingly used in clinical trials to assess the amount of selective serotonin reuptake inhibitor-induced ejaculation delay in men with premature ejaculation. Prospectively, stopwatch assessment of IELTs has superior accuracy compared with retrospective questionnaire and spontaneous reported latency. However, the IELT distribution in the general male population has not been previously assessed. Aim: To determine the stopwatch assessed-IELT distribution in large random male cohorts of different countries. Methods: A total of 500 couples were recruited from five countries: the Netherlands, United Kingdom, Spain, Turkey, and the United States. Enrolled men were aged 18 years or older, had a stable heterosexual relationship for at least 6 months, with regular sexual intercourse. The surveyed population were not included or excluded by their ejaculatory status and comorbidities. This survey was performed on a "normal" general population. Sexual events and stopwatch-timed IELTs during a 4-week period were recorded, as well as circumcision status and condom use. Main outcome measures: The IELT, circumcision status, and condom use. Results: The distribution of the IELT in all the five countries was positively skewed, with a median IELT of 5.4 minutes (range, 0.55-44.1 minutes). The median IELT decreased significantly with age, from 6.5 minutes in the 18-30 years group, to 4.3 minutes in the group older than 51 years (P<0.0001). The median IELT varied between countries, with the median value for Turkey being the lowest, i.e., 3.7 minutes (0.9-30.4 minutes), which was significantly different from each of the other countries. Comparison of circumcised (N=98) and not-circumcised (N=261) men in countries excluding Turkey resulted in median IELT values of 6.7 minutes (0.7-44.1 minutes) in circumcised compared with 6.0 minutes (0.5-37.4 minutes) in not-circumcised men (not significant). The median IELT value was not affected by condom use. Conclusion: The IELT distribution is positively skewed. The overall median value was 5.4 minutes but with differences between countries. For all five countries, median IELT values were independent of condom usage. In countries excluding Turkey, the median IELT values were independent of circumcision status.
Development and Validation of a New Questionnaire to Assess Sexual Satisfaction, Control, and Distress Associated with Premature Ejaculation
Article
Introduction. No validated questionnaires to assess the subjective aspects of premature ejaculation (PE) are currently in use. Clinical trials have generally only considered time, measured by ejaculatory latency, as an indicator of efficacy, but ejaculatory control, sexual satisfaction, and distress are important aspects of PE, which impact both the patient and his partner. The objective of this study was to develop and validate a new questionnaire to measure the overall experience of PE. Methods. The questionnaire was developed using four stages: item pool development, initial psychometric analyses, patient interviews, and final psychometric analyses. Results. An item pool of 17 was generated and reduced to 10 items through the initial psychometric analyses. Patient interviews did not require addition of further items and resulted in only minor modifications to item wording for clarity. Final psychometric analyses of the 10-item measure confirmed a three-factor solution: sexual satisfaction, control, and distress. Reliability was good, both internal consistency and test–retest reliability. Convergent validity using intravaginal ejaculatory latency time was excellent: control domain (0.75), sexual satisfaction domain (0.60), and distress domain (0.68). Known-groups validity was very good, all domain mean scores being statistically significantly worse in men with PE compared with the men reporting no PE problems. Conclusion. The Index of Premature Ejaculation is a reliable and valid questionnaire for the assessment of control over ejaculation, satisfaction with sex life, and distress in men with PE. This tool has the potential to add value to interpretations of improvements in ejaculation latency resulting from new treatments of PE. Althof S, Rosen R, Symonds T, Mundayat R, May K, and Abraham L. Development and validation of a new questionnaire to assess sexual satisfaction, control, and distress associated with premature ejaculation. J Sex Med 2006;3:465–475.